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Health Condition(s) or Problem
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Multiple Sclerosis
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Lay Summary
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The primary objective is to demonstrate that early intervention with Teriflunomide in
patients presenting with their first clinical episode consistent with MS prevents or delays
conversion to clinically definite Multiple Sclerosis [MS].
The secondary objectives are:
- to demonstrate that Teriflunomide prevents or delays conversion to MS based on the
revised McDonald Criteria and delays disability progression,
- to evaluate the long-term safety of Teriflunomide,
in this population.
(from ClinicalTrials.gov)
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Who can enter the trial
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Inclusion Criteria:
- First acute or subacute, well-defined neurological event consistent with
demyelination (i.e. optic neuritis confirmed by an ophthalmologist, spinal cord
syndrome, brainstem/cerebellar syndromes),
- Onset of MS symptoms occurring within 90 days of randomization,
- A screening MRI scan with 2 or more T2 lesions at least 3 mm in diameter that are
characteristic of MS.
Exclusion Criteria:
- Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major
systemic disease,
- Significantly impaired bone marrow function,
- Pregnancy or nursing,
- Alcohol or drug abuse,
- Use of cladribine, mitoxantrone, or other immunosuppressant agents such as
azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before
enrollment
- Any known condition or circumstance that would prevent in the investigator's opinion
compliance or completion of the study.
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.
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Who cannot enter the trial
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Inclusion Criteria:
- First acute or subacute, well-defined neurological event consistent with
demyelination (i.e. optic neuritis confirmed by an ophthalmologist, spinal cord
syndrome, brainstem/cerebellar syndromes),
- Onset of MS symptoms occurring within 90 days of randomization,
- A screening MRI scan with 2 or more T2 lesions at least 3 mm in diameter that are
characteristic of MS.
Exclusion Criteria:
- Clinically relevant cardiovascular, hepatic, neurological, endocrine or other major
systemic disease,
- Significantly impaired bone marrow function,
- Pregnancy or nursing,
- Alcohol or drug abuse,
- Use of cladribine, mitoxantrone, or other immunosuppressant agents such as
azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before
enrollment
- Any known condition or circumstance that would prevent in the investigator's opinion
compliance or completion of the study.
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.
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What will happen
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Drug; Teriflunomide (HMR1726); Tablet, oral administration once daily; Teriflunomide 7 mg; Teriflunomide 14 mg; Drug; Placebo; Matching tablet, oral administration once daily; Placebo
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Primary aim
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Conversion to clinically definite MS as defined by the occurrence of a relapse
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Secondary Aim
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Conversion to definite MS as demonstrated by the dissemination of cerebral Magnetic Resonance Imaging (MRI) lesions in time (revised McDonald criteria 2005); 108 weeks; No; Annualized relapse rate (number of relapses per subject/year); 108 weeks; No; Burden of disease; 108 weeks; No; Change from baseline in the volume of abnormal brain tissue as assessed by cerebral MRI; Disability progression as assessed by the Kurtzke Expanded Disability Status Scale (EDSS); 108 weeks; No; Patient reported fatigue as assessed by the Fatigue Impact Scale (FIS); 108 weeks; No
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Participant Information Sheet
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Sorry, not currently available
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Website
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Sorry, not currently available
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Recruitment Status
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Not Recruiting
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Nation
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England
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Location
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Liverpool, London, Newcastle upon Tyne, Nottingham, Plymouth, Salford, Sheffield
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